Conception control by a single monthly injection.

PIP: 73 women of childbearing age and proven fertility were injected with dehydroxy-progesterone acetophenide, 150 mg and estradiol enanthate, 10 mg on Day 7, 8, or 9 of a new cycle and on Days 7-9 in succeeding cycles for a total of 929 cycles (1-24 cycles/patient). Patients missing 1 or more injections because of failure to menstruate were started as new patients and no patient was restarted more than 3 times. 69% received 1 series of injections; 24% received 2 series; and 7% received 3 series. There was a moderate prolongation of monthly bleeding. Cycles averaged 2 days shorter than before therapy. There was absolute pregnancy protection. Discontinuation was 45% for this study, most during the first 5 cycles, 1/2 of drug related discontinuation due to abnormal bleeding. Cytology smears, breast examinations and endometrial biopsies repeated before and during therapy were unremarkable.^ieng

Endometriosis and the development of tuboperitoneal fistulas after tubal ligation.

The present study details gross and histologic findings of 79 previously ligated fallopian tubes from 3 groups of patients. Of 20 oviducts removed after documented sterilization failure (group I), 6 revealed a process compatible with endometriosis. Four of nine previously ligated fallopian tubes removed at the Johns Hopkins Hospital (group II) were successfully injected with India ink. In two patients histologic examination demonstrated the India ink in epithelium-lined spaces that lay beyond the muscle of the tubal wall extending from the tubal lumen to the serosal surface. Fifty oviducts were studied in twenty-five patients requesting reversal of their sterilizations (group III). A higher percentage of fistulas was demonstrated in patients with less than 4 cm of remaining proximal tubal segment. Furthermore, most of these fistulas were demonstrated in patients for whom 3 years had elapsed since the original sterilization procedure. Patients sterilzed by laparoscopic cautery methods were observed to have a higher percentage of fistula formation and histologic documentation of endometriosis at the sterilization site as compared with patients sterilized by other methods. Our observations suggest that ligation of the oviduct within 4 cm of the uterine cornu may predispose to the development of endometriosis and subsequent fistula formation in the tip of the ligated oviduct.

PIP: Gross and histological findings of 79 previously removed fallopian tubes from 3 groups of patients are reported. Of 20 tubes removed after documented sterilization failure (Group 1), 6 showed endometriosis. 4 of 9 previously ligated tubes (Group 2), were injected with ink; 2 patients showed ink in epithelium-lined spaces beyond the muscle of the tubal wall from the tubal lumen to the serosal surface. Group 3 was 50 oviducts from 25 patients requesting reversal of sterilizations. In this group a higher percentage of fistulas was demonstrated in those with less than 4 cm of tube remaining in the proximal segment. Also, most of these fistulas were in patients 3 years or more away from the original procedure. Laparoscopic cautery sterilizations had higher percentages of fistula formation and endometriosis at sterilization site than sterilizations by other methods. Therefore, ligation of the fallopian tube within 4 cm of the uterine cornu may predispose development of endometriosis and subsequent fistula formation at the tip of the ligated tube.

Comparison of the Lippes Loop D and tapered Lippes Loop D intrauterine devices.

The tapered Lippes Loop D (LLD) is compared to the standard LLD to evaluate efficacy and termination events. The tapered device was designed with the intention of lowering the expulsion rate below the rate for women with standard Lippes Loops. The two devices were randomly assigned to 989 women in two studies. Expulsion rates for the tapered device were lower at six months (p less than 0.10) and at 12 months (p less than 0.05). When the women were divided into groups by uterine measurement, the differences continued to be significant for women with larger uteri but not for those with smaller uteri. Comparison of other pertinent event rates showed no significant differences. Analysis of the data indicates that the tapered LLD represents an improvement in expulsion rates over the standard LLD.

Phase I prehysterectomy studies of the transcervical administration of quinacrine pellets.

To determine the safety of transcervical administration of quinacrine pellets as a method of voluntary female sterilization, three noncomparative Phase I clinical trials of the administration of 250 mg quinacrine were carried out in 21 women who were scheduled to undergo hysterectomy 24 h or one month later. Detailed results are presented for one of the trials using 10-min pellets. Six of 10 women had minor transitory complaints during the postinsertion 24-h follow-up period. Five women reported pelvic/abdominal cramping, one experienced headache, and one experienced dizziness. Blood chemistry values were not adversely influenced by the quinacrine. The average plasma level of quinacrine peaked at 3 h, 36.1 ng/ml, slightly lower than the value observed 4 h after oral administration of 200 mg in a previous study. An average of 27% of the administered dose was recovered in tampons. Quinacrine was detected in the plasma of two women at the four/six-week visit. Selected results are presented from two other trials that were halted because of slow recruitment. The transcervical administration of 250 mg of 10-min quinacrine pellets was well tolerated. However, based on recent mutagenicity testing and meetings with regulatory officials, it appears unlikely that the use of quinacrine for nonsurgical sterilization could be approved in the United States or Europe.

The use of prostacyclin analogue-containing suture for the prevention of postoperative venous thrombosis in the rat.

The ability of prostacyclin analogue incorporated into a controlled-release suture to prevent postoperative venous thrombosis was investigated. Thirteen rats underwent bilateral transection and anastomosis of the common femoral vein. In each animal, polycaprolactone suture containing 0.25 micrograms/cm of the prostacyclin analogue Iloprost (Schering Ag, Berlin, West Germany) was used to perform the anastomosis on one vessel. Similar suture without prostacyclin analogue was used on the contralateral vessel, which served as a control. Functional patency and luminal surface morphology were assessed 24 hours postoperatively. All anastomoses performed using suture containing prostacyclin analogue were patent. Among controls, five anastomoses were patent and eight were occluded. This difference was highly significant (p less than 0.005). All anastomoses performed with prostacyclin analogue-containing suture exhibited a uniform absence of thrombosis. In contrast, eight control veins exhibited a dense, well-organized fibrinous clot that filled the entire lumen, effectively sealing off the vessel. These results suggest that the prostacyclin analogue released from the suture was highly effective in inhibiting thrombus formation without adversely affecting the vessel's ability to achieve hemostasis.

Nonsurgical female sterilization.

The development of a safe, effective nonsurgical method of female sterilization that can be performed by paramedical personnel remains a high priority. The method should have a blind delivery system and require only one application. Methyl cyanoacrylate and quinacrine hydrochloride are the two most promising chemical agents. Quinacrine has evolved from instillations of a solution to the development of pellets to the use of an IUD vector. By using an IUD vector to deliver the quinacrine, tubal occlusion can be achieved with a reduction in total dosage and with one insertion instead of the three necessary with the solution and pellet methods.

Training: an integral adjunct to the introduction of newer methods of fertility regulation.

The provision of new technologies of fertility control that are known to be safer, simpler, and more effective may at first result in higher complication rates, particularly if training in the new techniques is inadequate. This was illustrated by analysis of data on several fertility control methods collected by the International Fertility Research Program. Various studies showed significantly higher complication rates earlier in the series than later, including one study in which complication rates fell dramatically after clinical training was provided. Another study showed the highest complication rate among the physicians performing the fewer number of cases. Finally, one analysis documented greater variability in several clinical criteria among the participating physicians than between the two pieces of equipment being compared. These data document that it is essential to train physicians and other staff members in the proper use of new equipment and techniques if the potential improvements offered by new technologies in fertility regulation are to be realized.

The history of pregnancies that occur following female sterilization.

Data on 208 pregnancies occurring among 20,749 women following sterilization were collected by the International Fertility Research Program and the histories of these pregnancies from conception to termination were analyzed. In the laparoscopic series, the operator's failure to interrupt the tube by electrocoagulation or a tubal occlusion device was the major reason reported for sterilization failure. In the culdoscopic series, operator error or device deficiency were the major reasons for failure. About three quarters of pregnancies in this study were conceived within the first year following sterilization and were confirmed during the first trimester. The rate of ectopic pregnancy occurring in this series was higher than the rate reported for nonsterilized women and was especially high when electrocoagulation was used.

PIP: The International Fertility Research Program collected data on 208 pregnancies occurring among 20,749 women following sterilization. The histories of these pregnancies were analyzed from conception to termination. The operator's failure to interrupt the tube by electrocoagulation or a tubal occlusion device was the major reason for sterilization failure in the laparoscopic series. Operator error or device deficiency were the causes for failure in the culdoscopic series. Three quarters of pregnancies in this study were conceived within the first year following sterilization and were confirmed during the first trimester. The rate of ectopic pregnancy occurring in this series was higher than the rate for nonsterilized women. It was especially high when electrocoagulation was used. From 1972 to August 1978, the pregnancies were reported to the Program. More than half the pregnancies were diagnosed by a test alone or a pelvic examination. In 38%, the reasons for failures were not reported. 123 of the 159 failures were terminated; the remainder were being continued at last follow-up. 15.7% of pregnancies were confirmed during the second trimester; 3.8% were diagnosed beyond the 25th week.

Laparoscopic sterilization with room air insufflation: preliminary report.

Laparoscopic sterilizations can be safely performed using room air insufflation. In a series of 400 procedures, the rates of surgical complications were comparable to other laparoscopy studies in which high-pressure gas was used. The purported problems associated with room air insufflation were not encountered in this study.

PIP: This paper reexamines the use of room air as the insufflating medium for voluntary sterilizations. 400 sterilization procedures were performed at the Centro Medico in El Salvador. The 1st 100 sterilizations utilized a standard laparoscopy technique that familiarized the operating physician with the laprocator. The next 300 sterilizations utilized Hasson's open laparoscopy technique using the Hasson trocar and blunt cannula. In all the procedures, pneumoperitoneum by room air was used for insufflation. Air insufflation was achieved using the KLI insufflator which can deliver either gas under pressure or air with a pneumatic bulb. No surgical recovery period or follow up complications were observed in the standard laparoscopy series. Of the 300 open laparoscopy procedures, 1 case (0.3%) of mesosalpingial injury without bleeding was recorded as a surgical complication. Follow-up complications were 2 cases (0.7%) of urinary tract infections and 2 cases (0.7%) of incision inflammation that required medical treatment with only aspirin or penicillin. Reported sites of pain during standard laparoscopic procedures were pelvic (5%) and shoulders (2%). Benefits of use of room-air insufflation are universal availability, low cost, simplification of procedure, reduction of cost of backup equipment and reduction of performance time. The reported disadvantages of room air insufflation--pain, air embolism, infection or death--did not occur in this series.

The introduction of postpartum intrauterine devices in the People's Republic of China.

In China, which has a commitment to family planning and, in particular, to the one-child family, a postpartum IUD should be widely accepted and could have significant impact on the Chinese family planning program. This report presents the introduction of the Delta T and Delta Loop devices, with 200 immediate postpartum insertions. Fifty-two deliveries were by cesarean section. The 6-month expulsion rates were 13.3 and 17.2 for the Delta T and Delta Loop, respectively. There was one pregnancy reported. Analysis suggests that the two devices are suitable for use in the postpartum period for Chinese women.

PIP: Since 1956, China has had an official policy favoring birth control, and in 1962, it became "a national policy of highest priority". The government began encouraging 3 reproductive norms: later marriage, with the legal age for marriage now being 22 for males and 20 for females; longer spacing between births, with at least 4-year interval recommended between births; and fewer children, meaning 2 children per family in 1977. Since then, a new family planning campaign has been introduced that calls for elimination of all 3rd and higher order births by 1982 in some areas and for encouraging the 1-child family as much as possible. Available contraceptives that can be provided by paramedics, which are highly effective, and which can be used in the immediate postpartum period while the woman is still under the care of birth attendants are recommended. The postpartum Loop and postpartum T intrauterine devices with biodegradable chromic sutures have been developed and named the Delta Loop and the Delta T. They are both modifications that involve the addition of chromic suture extensions to standard Lippes Loop D and Copper T 220C devices, respectively. From December 1980 through March 1981, 108 Delta T and 92 Delta Loop devices were inserted in women within 10 minutes following delivery of the placenta. 52 deliveries were by cesarean section. The 6 month expulsion rates were 13.3 and 17.2 for the Delta T and Delta Loop, respectively. There was 1 pregnancy reported. In a society such as the People's Republic of China where strong emphasis is placed on family planning and, specifically, on the 1-child family, the availability of a safe and highly effective contraceptive during the puerperium is ideal. Since the IUD itself has been proven effective and acceptable in China, a postpartum device could add another dimension to family planning, especially for couples not ready for permanent contraception.

Midtrimester pregnancy termination with prostaglandin E2 vaginal suppositories.

One hundred midtrimester pregnancies were randomly selected for elective termination with 20 mg prostaglandin E2 vaginal suppositories. The abortion rate was 93%. There were 66% complete abortions, 27% incomplete abortions and 7% failures. Mean insertion abortion time was 17 hours, 26 minutes. Average dosage was 82 mg. There were no mortalities but a high percentage of side effects, all of which were well tolerated. Two patients were admitted to other hospitals unfamiliar with termination technics, transfused and subjected to dilatations and curettages. There were no long-term sequelae.

Lamicel for induction of labor.

Lamicel is a synthetic osmotic cervical dilator currently used as a method of cervical dilation in first- and second-trimester pregnancy termination. It works by extracting fluid from the cervical tissue and softening the cervix. This study evaluated its effectiveness in nonelective medical induction of labor in high-risk patients. Forty inpatients who, for medical and obstetric reasons, required delivery within the next 24-48 hours were studied. Patients were evaluated to make certain that a 12- to 24-hour delay was safe for mother and child. The evening prior to the day of induction, a pelvic examination determined the Bishop score, and bacterial cultures were obtained from the endocervix. As many Lamicels as possible (usually one to three) were then placed in the endocervix without rupturing the membranes. The next morning the devices were removed, a repeat Bishop score obtained, amniotomy performed, internal monitors placed and oxytocin infusion initiated. Data were collected for preinsertion and postinsertion Bishop scores, induction-delivery times, duration of ruptured membranes, and cesarean and vaginal birth rates. Maternal and neonatal infectious morbidity was determined. A comparison group of patients with premature rupture of the membranes was selected. From data studied at our institution, patients were matched for parity and duration of labor (not significantly different from the Lamicel group). The study revealed that Lamicel can be an effective means of ripening the cervix for induction of labor.

Menstrual pattern changes in laparoscopic sterilization patients whose last pregnancy was terminated by therapeutic abortion. A two-year follow-up study.

Women were used as their own controls in the comparison of presterilization and poststerilization menstrual patterns. Five parameters were studied: regularity of cycle length, duration and amount of flow and incidence of dysmenorrhea and intermenstrual bleeding. Three parameters in the electrocoagulation group (regularity of cycle length and duration and amount of flow) and one parameter in the tubal ring group(duration of flow) showed significant changes after sterilization. However, by controlling for the effect of previous contraceptive methods used, no significant menstrual pattern changes following sterilization were discerned in either technique group.

PIP: Between 1973 and 1975, 2501 women were sterilized by laparoscopy at the Yonsei University College of Medicine in Seoul, Korea. The women were used as their own controls in a follow-up study of the changes in menstrual patterns following sterilization. Tables present the results of the study. In the electrocoagulation group, twice as many patients changed from regular to irregular cycles than the other way; there was no such difference among the tubal occlusion group. More patients in both groups experienced a decline in menstrual flow. The aging of the patients and the fact that some had had therapeutic abortions prior to or concurrent with the sterilization procedure did not have any effect on the observed changes in menstrual cycles. Changes in menstrual cycle length, duration, and amount seemed to be associated with the type of contraceptive used previously. Controlling for prior contraceptive usage caused the observed differences in menstrual cycles to disappear.

Postpartum insertion of modified intrauterine devices.

The immediate postpartum insertion of standard intrauterine devices (IUDs) and those specially modified for postpartum use was evaluated in a multicenter clinical trial. The immediate postpartum insertion of IUDs was not associated with any increased risk of perforation or infection, although expulsion rates were higher than with interval insertions. The expulsion rate varied widely between centers using similar devices, suggesting that training in insertion is essential. Postpartum IUD insertions can be a practical contraceptive option for patients and providers of medical services.

PIP: The postpartum insertion of IUDs, especially in the case of institutional deliveries, has a number of advantages, including ease of insertion, availability of skilled personnel, appropriate facilities, and convenience for the mother. Immediate postpartum insertion of IUDs is not associated with increased risk of perforation or pelvic inflammatory disease (PID), although expulsion rates are higher than with interval insertions. In studies by Family Health International (FHI), expulsion rates varied widely between centers using similar devices. Expulsion rates ranged from 6-37/100 women at 6 months after insertion. This finding suggests that insertion may be as important a factor in influencing expulsion as the configuration of the device. FHI has developed modified IUDs with added suture material to project into the endometrium and reduce expulsion. After insertion the suture projections become soft and pliable and biodegrade completely within 6 weeks. Standard IUDs used for modification were the TCu and Lippes Loop. Adequate training and supervision of delivery room staff in insertion of IUDs is necessary. Midwives can betrained to insert the IUD after parturition through demonstrations and followup monitoring. Timing of IUD insertion is very important; FHI data show a significantly higher (p0.05) expulsion rate associated with insertions performed within the period of 10 minutes to 36 hours as compared to the immediate postpartum period (within 10 minutes). The use of postpartum IUDs raises questions of how much overlap there will be with the natural suppression of ovulation, especially in breastfeeding women, and whether the altered physiology of the reproductive tract interacts with the method. The inability to predict for individual women when ovulation will return, particularly among those who are breastfeeding, combined with inconvenience and sometimes impossibility of returning to a medical facility for insertion make the compromise of immediate postpartum insertion demographically effective and reasonable in many circumstances.

Management of breech presentations in developing country hospitals.

PIP: This paper reports the results of an analysis of singleton breech presentations, alive at the onset of labor and with no congenital anomalies. There is no significant benefit from abdominal delivery for small or very small babies because developing country hospitals lack the neonatal care facilities to care for the low birth weight babies. For babies over 2500 grams, vaginally delivered babies are more than twice as likely to die before their mothers are discharged from the hospital. Parous women are more likely than are primipara to safely deliver breeches vaginally. In developing countries the possibility of maternal morbidity is at once greater and more serious because of fewer resources to provide adequate care. In deciding whether to deliver a breech abdominally or vaginally physicians should ask the following questions: 1) Are neonatal care facilities adequate for the small baby delivered alive? 2) What is the mother's parity and what are her future reproductive plans? 3) Will future deliveries occur at home or in a hospital? 4) Will she consider tubaligation at the time of cesarean section? 5) What is the hospital's record of maternal morbidity and mortality for cesarean sections? and 6) What is the physician's skill in delivering breeches vaginally and in performing cesarean sections?^ieng